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To remove food and debri from the mouth resulting in fresher breath.

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This document is a 510(k) premarket notification letter from the FDA regarding a device called "Breath Ace Breathfreshener." It does NOT contain information about acceptance criteria or a study proving that a device meets acceptance criteria.

The document states that the FDA has reviewed the 510(k) for the "Breath Ace Breathfreshener" and determined it to be substantially equivalent to devices marketed prior to May 28, 1976. This is a regulatory approval notice, not a study report.

Therefore, I cannot provide the requested information based on this document. The document primarily focuses on:

• Substantial Equivalence: The FDA's determination that the Breath Ace Breathfreshener is substantially equivalent to a predicate device.
• Regulatory Classification: The device is classified as "Unclassified."
• Indications for Use: "To remove food and debris from the mouth resulting in fresher breath."
• General Controls: The device is subject to general controls provisions of the Act (registration, listing, good manufacturing practice, labeling, prohibitions against misbranding and adulteration).

There is no mention of performance metrics, clinical studies, sample sizes, expert opinions, ground truth, or MRMC studies for this device within the provided text.

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